US Medical Device Submissions
Navigating the FDA submission
channels takes experience.
The Fang Consulting team have a solid understanding of medical device development and can partner with you from development, through testing and submission, to a smooth market entry. Your success is our goal.
The Fang team has experience with FDA submissions. Whether you need a 510(k) or a PMA, we can guide you through the process.
Our staff provides FDA guidance at any step of the process, so your company has a smooth and successful market launch. From providing strategic pathways to leading pre-submission meetings, writing submissions, and answering the FDA’s requests for Additional Information (AIs), the Fang team of consultants are able to lend assistance where needed to get your device on the market successfully.
US Services
- 510(k) Submissions
- Medical device classification review
- Medical device Product Code review
- Predicate determination
- PMA Submissions
- Q-Submission Meetings
- Pre-Submissions (Pre-Subs)
- Submission Issue Requests (SIRs)
- Study Risk Determinations
- Informational Meetings
- PMA Day 100 Meetings
- Agreement and Determination Meetings
- Breakthrough device meetings
- STeP Meetings
- Accessory Classification Request Meetings
- Feedback for specific questions
- PowerPoint presentation
- Team rehearsals
- Regulatory Strategy Plans (at all stages of development)
- Change Assessments
- Determine if a new submission is required
- For individual changes and accumulative impact of multiple changes
- Risk Assessments
